Page 3 - Usfda

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Pharma in bitter health: Stocks sink upto 38% in 2025; time to bottom fish?

Among stocks, Natco Pharma plunged 37.85%, Ipca Labs 22.43%, Aurobindo Pharma 17.99%, and Sun Pharma 14.30%. Other laggards include Lupin (13.25%), and Dr Reddy's (5.17%).

Caplin Point's unit gets USFDA nod for generic milrinone lactate injection

Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing. The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said. Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent ...

Lupin share price rises 3% as USFDA okays schizophrenia drug; details

Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension

Sun Pharma slips 5% in 2 days, nears 52-wk low; why drug stock trades weak?

Thus far in August 2025, Sun Pharma has underperformed the market by falling 8 per cent, as compared to a 1 per cent decline in the BSE Sensex

US pharma tariffs unlikely to hit Indian drugmakers materially: Ind-Ra

Ind-Ra said US tariffs may cause only short-term pricing impact for Indian pharma as firms remain fortified by diversification, strong balance sheets, and global market positioning

Albertsons looks to make in India for the global market: Sunil Gopinath

Gopinath talks about his strategies and priorities as Albertsons plans to hire about 1,000 employees in the next 18 months and what will fuel the next phase of GCC growth in the country

Alembic gets USFDA's approval for generic acne drug Tretinoin Cream

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.

Poly Medicure to invest ₹500 cr in new plants for global market push

Poly Medicure to set up three plants in Faridabad, Haridwar, and Jaipur for dialysis, cardiology, and oncology devices, targeting US, Europe, and Brazil markets by FY28

Zydus gets USFDA approval for a high blood pressure to treat angina

Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a drug used to treat angina and high blood pressure. The company has received final approval from the US Food and Drug Administration (USFDA) for Diltiazem Hydrochloride tablets in strengths of 30 mg, 60 mg, 90 mg, and 120 mg, the drug maker said in a statement. Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. It belongs to a class of drugs called calcium-channel blockers. Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle. The company said Diltiazem Hydrochloride Tablets will be produced at Zydus Lifesciences' Baddi plant in Himachal Pradesh. As per IQVIA MAT June 2025 data, Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 million in the US.

Zydus Lifesciences up 2% after USFDA nods Diltiazem Hydrochloride tablets

Zydus Lifesciences share price rose 2 per cent, logging an intra-day high at ₹955 per share on BSE after USFDA gave its approval for Diltiazem Hydrochloride Tablets.

India launches formal rules to fix, streamline drug and device clearances

India has issued first official guidelines for expert panels to bring consistency, speed, and transparency to drug and device approvals amid a broader regulatory overhaul

Sun Pharma, Lupin, Dr Reddy's recall products in US due to mfg issues

Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. The medication is used to treat attention deficit hyperactivity disorder (ADHD). The drug firm initiated the Class II recall in the US on June 16 this year, it added. Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (US

Zydus Lifesciences gets tentative USFDA nod for generic blood cancer drug

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets. The tentative approval granted by the US Food and Drug Administration (USFDA) is for Ibrutinib tablets of strengths 140 mg, 280 mg, and 420 mg, Zydus Lifesciences said in a statement. The Ibrutinib tablets will be produced at Zydus Lifesciences Ltd SEZ, Ahmedabad, it added. The company said Ibrutinib is indicated for the treatment of adult patients with different types of blood cancers, Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL), and Waldenstrom's macroglobulinemia (WM). Citing IQVIA MAT May 2025, Zydus said Ibrutinib tablets had annual sales of USD 2148.9 million in the US.

Dr Reddy's gets 7 USFDA observations after Srikakulam plant inspection

A Form 483 is issued by the US health regulator when inspectors identify conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act or relevant guidelines

Biocon Biologics expands diabetes portfolio with FDA approval for Kirsty

Interchangeable biosimilar to NovoLog in the US and will be available in prefilled pens and vials

Zydus Lifesciences gets USFDA nod for its painkiller Celecoxib capsules

The company said that the medicine is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain

Alembic Pharma gets USFDA nod for generic cancer treatment injection

Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation, it added. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said. Citing IQVIA data, Alembic said Doxorubicin Hydrochloride Liposome injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) single-dose ...

Aurobindo Pharma recalls over 4,600 bottles of painkiller in US market

The drug, Acetaminophen Tablets (325 mg), is being recalled due to manufacturing deviations from Current Good Manufacturing Practices, following complaints of brown tablet discolouration

US FDA to fast-track drug reviews for firms backing national priorities

US regulators will begin offering faster reviews to new medicines that administration officials deem as promoting the health interests of Americans, under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to challenge assumptions and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of national priority vouchers to companies aligned with U.S. national priorities,